A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD

Mayo Clinic

Status: Completed

Conditions: Obsessive-Compulsive Disorder; Anxiety Disorders

Treatments: Behavioral: Parent Coached Exposure Therapy - Individualized; Behavioral: Cognitive Behavior Therapy; Behavioral: Parent Coached Exposure Therapy - Group (removed from study)

Study type: Interventional

Funder types: Other

Identifiers

NCT05777161

20-008982

Details and patient eligibility

About

The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety disorders and obsessive compulsive disorder (OCD).

Full description

The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) through baseline comparisons, to compare effectiveness of individual PCET and individual standard cognitive behavioral therapy (CBT), to compare efficiency of individual PCET and individual standard CBT, to compare effectiveness of group intensive PCET, individual PCET, and individual standard CBT, and acceptability.

Enrollment: 162 patients

Sex: All

Ages: 7 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a DSM-5 anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, agoraphobia, separation anxiety disorder, social and specific phobias, as assessed on the relevant modules of the (MINI-Kids; (Sheehan et al., 2010) by study staff in the PADC.
• Be appropriate for the PADC standard outpatient therapy program, and be interested in starting outpatient therapy,
• Have the anxiety disorder as their primary diagnosis,
• If taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic medication, had no medication changes made at least 8 weeks prior to initiating participation in the study and agree to no changes during the 12 weeks of the study.

Exclusion criteria

• History of and/or current psychosis, autism, bipolar disorder, or current suicidality, or eating disorder as assessed during the initial clinical interview and all available clinical information.
• Current positive diagnosis in the child's caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives (based on clinical interview).
• Secondary diagnosis of oppositional defiant disorder or major depression of sufficient severity to prevent anxiety treatment.
• Severity of symptoms that warrant higher level of care (i.e. intensive, residential, IOP, inpatient)
• Family is unable to attend weekly sessions (i.e. geographical or scheduling barriers)
• History of good quality exposure or CBT.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 3 patient groups

Parent Coached Exposure Therapy-Individual (PCET-I) Group

Experimental group

Description:

Subjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy

Treatment:

Behavioral: Parent Coached Exposure Therapy - Individualized

Traditional Cognitive Behavior Therapy (CBT) Group

Active Comparator group

Description:

Subjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy

Treatment:

Behavioral: Cognitive Behavior Therapy

Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study)

Experimental group

Description:

Subjects will receive 5 day (nine sessions) of group-based Parent Coached Exposure Therapy delivered within a span of five days (Monday through Friday), followed by 5 weeks of self-care

Treatment:

Behavioral: Parent Coached Exposure Therapy - Group (removed from study)